Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT02860702
Eligibility Criteria:
Inclusion Criteria:
1. Term infants (≥37 and 0/7 weeks gestational age) ≤ 7 days old with a diagnosis of single ventricle physiology who are thought to require a single ventricle repair at the time of enrollment.
2. Infant feeding was NPO or consisted of 100% human milk diet prior to enrollment
3. Parent(s) willing to sign informed consent.
4. Parent(s) willing to comply with study follow-up procedures.
5. Require surgical palliation within the first 1 month of life.
Exclusion Criteria:
1. Term infants \>7 days old at the time of diagnosis.
2. \<37 weeks gestation
3. Infants requiring cardio-pulmonary resuscitation prior to surgical repair.
4. Outborn infants who received enteral nutrition at the other institution prior to surgical repair. If it is uncertain if infant received even 1 bottle or a small amount of formula, infants will be excluded.
5. Major congenital abnormalities that could significantly affect survival such as:
1. Confirmed or suspected major genetic abnormalities (lethal or with extremely low probability for survival).
2. Chromosomal abnormalities: Trisomies (13, 18, 21 etc.) deletions or translocations (Turner/Williams Syndrome, DiGeorge, to name a few)
3. Major organ system abnormalities not related to a genetic syndrome that are lethal or have extremely low probability for survival (i.e, bilateral kidney intrinsic disease, pulmonary hypoplasia, Central Nervous System (CNS) malformations: Arnold Chiari, myelomeningoceles, hydranencephaly, schizencephaly, holoprosencephaly))
4. Heterotaxia
5. Metabolic disorders affecting growth: homocystinuria, methylmalonic acidemias, propionic acidemias, urea cycle defects
6. Evidence of intracerebral hemorrhage (IVH) ≥ Grade 3
7. Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival.
8. Requires Extracorporeal Membrane Oxygenation (ECMO) pre-operatively
9. Legally Authorized Representative(s) unwilling to comply with an exclusive human milk diet either in the form of mother's milk, human milk-based human milk fortifier, human milk based caloric fortifier or donor human milk during the initial hospitalization period and through the 30 day feeding period after surgical repair or hospital discharge, whichever comes first.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
7 Days
Study:
NCT02860702
Study Brief:
Protocol Section:
NCT02860702